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Drug Combinations for Multiple Myeloma
Study Summary
This trial studies 3 treatment combos of 4 drugs to find best way to treat newly diagnosed multiple myeloma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have been diagnosed with multiple myeloma according to IMWG criteria within the last 28 days.My diabetes is under control as shown by recent tests.You need to have certain lab test results within 28 days before joining the study.I have chronic hepatitis B but it's undetectable with treatment.I can take care of myself and am up and about more than half of the day.You need to have a detectable and measurable disease within 28 days before joining the study, as determined by specific guidelines.You need to have had a full body scan within the last 60 days before joining the study.I do not have severe nerve damage in my hands or feet.I have kidney problems but am not on dialysis.If you are considered "frail," your hemoglobin level must be at least 7 g/dL within the past 28 days.I am HIV positive, on treatment, and my latest viral load is undetectable.I had hepatitis C but have been treated and cured.If you are considered "frail," your platelet count must be at least 50 x 10^9/L within the 28 days before joining the study.My heart is healthy enough for treatment, as confirmed by a doctor recently.Participants must be categorized as frail or intermediate fit based on a myeloma frailty index within the last 28 days before joining the study.My blood or urine tests show signs of multiple myeloma.I've had a full medical check-up in the last 28 days.Your absolute neutrophil count must be at least 0.75 x10^9/L within the last 28 days before joining the study if you are considered "frail."My myeloma frailty score is either frail or intermediate.I can complete surveys in English or Spanish and agree to do so for the study.My condition is at stage III according to the R-ISS.I do not have another cancer that could affect this treatment's safety or results.I have not had systemic therapy for my multiple myeloma, except in specific cases.
- Group 1: Arm II (DRd-R)
- Group 2: Arm I (VRd-Lite)
- Group 3: Arm III (DRd-DR):
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the regulatory body approved Arm II (DRd-R) for public use?
"Our team at Power believes Arm II (DRd-R) is fairly safe, as it has achieved a score of 3 after multiple rounds of data collection that have shown both efficacy and safety."
Are there any openings for volunteers in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively enrolling participants and was first posted on June 1st 2023; the last edit was made May 30th 2023. 510 patients are required from a single location."
What are the desired outcomes of this experiment?
"This 10-year clinical trial intends to measure overall survival (OS) between two study arms. As well, progression-free survival (PFS), patient report outcomes (PRO), quality of life (QOL) and minimal residual disease (MRD) will also be evaluated through stratified log rank test, EORTC QLQ-C30 v3 questionnaire, and binomial tests respectively."
How many human subjects are participating in this trial?
"Affirmative, the information on clinicaltrials.gov testifies that this investigation is actively accepting enrollees. The trial was initially posted on June 1st 2023 and has been revised recently on May 30th 2023. Presently there are 510 participants being recruited from a single site."
Who else is applying?
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What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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